Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-12-31

Brief Summary

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Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.

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Detailed Description

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To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FEC3-D3

3 cycles of FEC followed by 3 cycles of Docetaxel

Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks

Docetaxel 75 mg/m2, every 3 weeks

Group Type ACTIVE_COMPARATOR

FEC3-D3

Intervention Type DRUG

Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks

Docetaxel 75 mg/m2, every 3 weeks

AC4-D4

4 cycles of Adriamycin plus Cyclophosphamide (AC) followed by 4 cycles of Docetaxel

Adriamycin 60 mg/m2, every 3 weeks Cyclophosphamide 600 mg/m2, every 3 weeks

Docetaxel 75 mg/m2, every 3 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FEC3-D3

Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks

Docetaxel 75 mg/m2, every 3 weeks

Intervention Type DRUG

Other Intervention Names

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5-FU Pharmorubicin Cytoxan Docetaxel

Eligibility Criteria

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Inclusion Criteria

* Performance status 0 or 1
* Clinically stage 2 or 3 with histologically proven lymph node involvement
* Tumor or lymph node greater than 1.5 cm

Exclusion Criteria

* Pregnancy or lactation
* Prior chemotherapy or radiotherapy for any malignancy
* Documented history of cardiac disease contraindicating anthracyclines
* Currently active infection

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No